The Recall Desk
ModerateFDA (Devices)·Z-1049-2023·Announced 2023-02-08

Lucid TCD 2.0 Transcranial Ultrasound System Recalled for Hard Drive Failure

The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is device hardware failure resulting in inoperability rather than direct patient harm.

Plain-English summary

The Lucid TCD 2.0 System, Model NA-LUCM1, is a transcranial Doppler ultrasound device manufactured by NovaSignal Corp. The device has been recalled due to a faulty hard drive that affects its operation.

The faulty hard drive causes the system to freeze and reboot. While the system initially restarts to a normal operating state, the hard drive failure will eventually render the entire system inoperable, preventing its use for patient care.

This recall affects six units distributed across the United States and internationally. If you have one of the affected devices, contact NovaSignal Corp. for instructions on inspection, repair, or replacement.

The recalled product

Product
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Manufacturer
NovaSignal Corp.
Category
Medical Device — Ultrasound / Doppler System
Hazard
  • hardware-failure
  • system-inoperability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • UDI-DI/Serial Numbers: 00850681007221/ 21020003
  • 20080004
  • 20100004
  • 21080001
  • 20120001
  • 00850681007009/ 19090005

Distribution

Distributed nationwide across the United States.

Related recalls

Same category